Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Case studies, hypotheticals, and ample time for discussion are provided.

Agenda Highlights

  • Organizational structure of the FDA
  • Concepts and statutes in food law and regulation, and the relationship between state and federal jurisdiction
  • Principles of food labeling requirements and litigation risks as shaped by FDA, the Federal Trade Commission (FTC), and class action litigation
  • Role of inspection and enforcement authorities and practical steps toward compliance
  • Food safety frameworks, including review of Food Safety Modernization Act (FSMA) final rules and guidance for industry
  • International issues that affect food law and regulation in the United States
  • Dietary supplement oversight and the regulation of cosmetics

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Federal Meat, Poultry, and Egg Products Inspections
  • Federal Trade Commission 15 U.S. C. § 41 et. seq.
  • Lanham Act – 15 U.S.C. §1051 et seq.

Attendee Resources

These valuable takeaways will be provided:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Register

Industry & Firms

$999
  • +$250 for non-members

Non-Profit

$849
  • +$100 for non-members

Government

$849
  • +$100 for non-members

Academic

$849
  • +$100 for non-members

Student

$99
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Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

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Agenda

subject to change

Curriculum Advisor: Ann M. Begley, Partner, Wiley LLP

Tuesday, September 21

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Overview of U.S. Food Law and Regulation
T. Daniel Logan, Associate, Kleinfeld, Kaplan & Becker, LLP

1:05–1:15 PM
Break

1:15–2:20 PM
Food Safety: Ingredient Preclearance/Intentional Components of Food
Natalie Rainer, Partner, Keller and Heckman LLP

2:20–2:35 PM
Break

2:35–3:50 PM
Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food
Charles M. Breen, IndependentConsultant, EAS Consulting Group

3:50–4:00 PM
Break

4:00–5:00 PM
 U.S. Department of Agriculture
Brian Sylvester, Special Counsel, Covington & Burling LLP

 

 

Wednesday, September 22

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Food Derived from Biotechnology – the USDA/FDA Conundrum
Ann M. BegleyPartner, Wiley LLP

1:05–1:15 PM
Break

1:15–2:25 PM
Food Labeling: General Requirements (Including Meat and Poultry)
Steven Armstrong, Senior Regulatory Advisor, Haynes and Boone LLP

2:25–2:35 PM
Break

2:35–3:45 PM
Food Labeling: Nutrient Content, Health and Other Claims
Todd A. Harrison, Partner, Venable LLP

3:45–3:55 PM
Break

3:55–5:00 PM
Advertising: The Federal Trade Commission and Private Rights of Action
Cynthia L. Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP

 

 

Thursday, September 23

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:20 PM
Dietary Supplements
Megan Olsen, Vice President & Associate General Counsel, Council for Responsible Nutrition

1:05 – 1:15 PM
Break

1:15 – 2:15 PM
The Regulation of Cosmetics
Raqiyyah Pippins, LifeSciences and Healthcare Regulatory Partner, Arnold & Porter LLP

2:15–2:30 PM
Break

2:30–3:45 PM
Inspection and Enforcement Authority

3:45–4:00 PM
Break

4:00 – 5:00 PM
Imports and International Issues
John F. Johnson, III, Of Counsel, Shook, Hardy & Bacon LLP

5:00 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.